None listed
Conditions
Interventions
Intervention1: Respiratory Syncytial Virus Vaccine: Participants will receive 1 dose of RSV Vaccine 120 mcg at Visit 1
Control Intervention1: Placebo for RSV Vaccine: Participants will receive 1 dose
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants of age 18 or older 2. Participants who are ambulatory and live independently in the community 3. Participants who are determined by medical history, physical examination if req, and clinical judgment of the investigator to be eligible for inclusion in the study. 4. Applicable to participants 18 through 59 years of age - Participants who are healthy or have stable preexisting diseases. These participants are considered at high risk of RSV disease by having at least 1 reportable stable chronic medical condition(s). 5. Participants who are willing and able to comply with scheduled visits, laboratory tests, lifestyle considerations, and other study procedures, including daily completion of the e-diary for 7 days after study vaccination. 6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions as applicable.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 1. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 2. History of severe adverse reaction associated with a vaccine and-or severe allergic reaction eg, anaphylaxis to any component of the study interventions or any related vaccine. 3. Prior history of any subtype of Guillain-Barr syndrome of any etiology. 4. Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator s opinion, excludes the participant from participating in the study. 5. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and-or laboratory-physical examination. 6. Any medical or psychiatric condition, including recent i.e. within the past year or active suicidal behavior or laboratory abnormality, that may increase the risk of study participation or, in the investigator judgment, make the participant inappropriate for the study. 7. Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation. 8. Receipt of investigational or approved monoclonal antibodies against RSV within 6 months before study intervention administration. 9. Receipt of blood or plasma products, immunoglobulins, or monoclonal antibodies that are considered immunosuppressive, from 60 days before study intervention administration or planned receipt throughout the study. 10. Receipt of treatment with known systemic immunosuppressant medications, or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. 11. Receipt of systemic corticosteroids less than 20 mg-day of prednisone or equivalent for less than 14 days, within 60 days before enrollment or planned receipt through conclusion of the study. 12. Participation in other studies involving an investigational product within 28 days prior to consent and-or during study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To describe the safety profile of RSVpreF when administered to adults more than 18 years of age 2. To describe the immune responses elicited by RSVpreFTimepoint: 1.To describe the safety profile of RSVpreF when administered to adults more than 18 years of age 2. To describe the immune responses elicited by RSVpreF | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactDr Seema Pai
Pfizer Limited
Outcome results
None listed